Application 021861

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PATANASE	OLOPATADINE HYDROCHLORIDE	SPRAY, METERED;NASAL	0.665MG/SPRAY	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021861-001	PATANASE	OLOPATADINE HYDROCHLORIDE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021861-001	PATANASE	0.665MG/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SPRAY, METERED / NASAL		RLD	2008-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL		RLD	2008-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021861-001	PATANASE	0.665MG/SPRAY	SPRAY, METERED / NASAL	AB	RLD, RS	2008-04-15	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021861-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021861-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021861-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021861-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021861-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021861-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021861-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021861-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021861-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021861-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021861-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021861-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021861-001	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	N021861-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021861-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021861-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021861-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021861-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021861-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 90 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021861-001	8399508	2022-09-17	U-726		2013-03-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021861-001	7977376	2023-02-02		Drug product	2011-07-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021861-001	8399508*PED	2023-03-17		Pediatric extension		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021861-001	7977376*PED	2023-08-02		Pediatric extension		`c0c555d07b60…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 4 · 68 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Sportpharm LLC	f0cc699c-545d-4097-b85d-b67ba550863c	2026-04-24	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
Retaine Allergy	OLOPATADINE HYDROCHLORIDE	OCuSOFT LLC	e0a01606-275d-448c-8838-ca46f1e612e5	2026-04-23	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Best Choice	04c7b08c-52c1-427c-8b8f-fe67444fbca4	2026-04-22	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride Ophthalmic Solution	OLOPATADINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	5295f8a2-4e0d-4b6e-9807-e2f36b1d5d15	2026-04-15	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	BluePoint Laboratories	3e86783f-0001-625f-e063-6294a90acd20	2026-03-25	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	Somerset Therapeutics, LLC	6ee9f8f5-973c-4c71-8069-e76cd87b07dc	2026-03-25	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
Eye Allergy Itch Relief	OLOPATADINE HYDROCHLORIDE	CARDINAL HEALTH 110, LLC. DBA LEADER	5d79fc06-a25f-debb-f08b-523ff26df900	2026-02-24	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine Hydrochloride	OLOPATADINE HYDROCHLORIDE	Rugby Laboratories	95424539-7883-2da3-8a46-3d1a19259e15	2026-02-17	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	AmerisourceBergen Drug Corp	18f851e3-24c6-44fd-8376-0f5418ded9a9	2026-02-16	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
Eye Allergy Itch and Redness Relief	OLOPATADINE HYDROCHLORIDE	CARDINAL HEALTH 110, LLC. DBA LEADER	5255d142-7d04-ab80-fa97-b11c4486e42c	2026-02-13	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	YYBA Corp	47f8ae9b-d92b-4bcb-e063-6294a90af45a	2026-02-03	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
Eye Allergy Itch Relief	OLOPATADINE HYDROCHLORIDE	TARGET CORPORATION	aa112cbd-35c0-a723-48cc-21137332b2c3	2026-02-03	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	GLENMARK THERAPEUTICS INC., USA	07e8b359-d4ae-4b5b-81dc-c7e57e172c58	2026-01-27	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine HCl	OLOPATADINE HYDROCHLORIDE	Rugby Laboratories	edb068e2-1835-483e-e59c-bcbe13b66d76	2026-01-22	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	1c7d2342-ba1c-4244-9814-d92a05725d4e	2026-01-20	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
PATADAY TWICE A DAY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	b7a24375-25df-4405-aa7c-34c46af51194	2026-01-20	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
PATADAY ONCE DAILY RELIEF	OLOPATADINE HYDROCHLORIDE	Alcon Laboratories, Inc.	6d07a5d6-265c-4735-97b3-8a2575b276cb	2026-01-20	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	WALGREEN COMPANY	26703751-00c4-451b-a5be-242da9cd2b88	2025-12-16	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
Olopatadine hydrochloride	OLOPATADINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	ec0c8c56-68d2-e63e-e053-2995a90a8db2	2025-11-24	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	A-S Medication Solutions	7c89196a-cf74-4ce3-a9fd-b3d42a9e2a19	2025-11-18	Warnings	Name fallback generic name: OLOPATADINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0065-0332	PATANASE	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0332	PATANASE	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0332	PATANASE	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0332	PATANASE	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0332	PATANASE	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0065-0332	PATANASE	olopatadine hydrochloride	Alcon Laboratories, Inc.	NDA	Current
0078-0834	PATANASE	olopatadine hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0834	PATANASE	olopatadine hydrochloride	Novartis Pharmaceuticals Corporation	NDA	Current
61314-320	Olopatadine Hydrochloride	olopatadine hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
61314-320	Olopatadine Hydrochloride	olopatadine hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
61314-320	Olopatadine Hydrochloride	olopatadine hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66749	SUPPL	2021-03-11
66550	SUPPL	2021-03-05
16475	SUPPL	2015-11-04
6327	SUPPL	2015-10-28
6326	SUPPL	2012-02-27
37779	SUPPL	2012-02-24
28731	SUPPL	2010-04-05
37778	SUPPL	2010-04-04
42330	ORIG	2010-03-19
28730	SUPPL	2010-01-26
37777	SUPPL	2009-12-02
37776	ORIG	2008-04-23
6325	ORIG	2008-04-22
53361	ORIG	1900-01-01
53360	ORIG	1900-01-01
53359	ORIG	1900-01-01
53358	ORIG	1900-01-01
53357	ORIG	1900-01-01
53356	ORIG	1900-01-01